Table 1.
Patient characteristics at baseline.
| No. (%) | P | |||||
|---|---|---|---|---|---|---|
| Characteristics | Intervention (n = 63) |
Control (n = 64) |
||||
| Age, years (mean, range) | 37.6 | (18-72) | 37.1 | (18-77) | 0.925d | |
| Female | 34 | (54.0) | 35 | (54.7) | 1.000e | |
| Male | 29 | (46.0) | 29 | (45.3) | 1.000e | |
| IBD | Crohn’s disease (CD) | 40 | (63.5) | 45 | (70.3) | 0.678f |
| Ulcerative colitis (UC) | 20 | (31.7) | 17 | (26.6) | 0.678f | |
| IBD-unclassifieda | 3 | (4.8) | 2 | (3.1) | 0.678f | |
| Montreal Classification UC | ||||||
| E1 | 3 | (4.8) | 4 | (6.3) | 0.368f | |
| E2 | 4 | (6.3) | 6 | (9.4) | 0.368f | |
| E3 | 13 | (20.6) | 7 | (10.9) | 0.368f | |
| Montreal Classification CD | ||||||
| A1 | 13 | (20.6) | 8 | (12.5) | 0.295f | |
| A2 | 25 | (39.7) | 35 | (54.7) | 0.295f | |
| A3 | 2 | (3.2) | 2 | (3.1) | 0.295f | |
| L1 | 13 | (20.6) | 16 | (25.0) | 0.622f | |
| L2 | 5 | (7.9) | 2 | (3.1) | 0.622f | |
| L3 | 21 | (33.3) | 25 | (39.1) | 0.622f | |
| L1 + 4 | 1 | (1.6) | 2 | (3.1) | 0.622f | |
| B1 | 15 | (23.8) | 16 | (25.0) | 0.942f | |
| B2 | 11 | (17.5) | 13 | (20.3) | 0.942f | |
| B3 | 7 | (11.1) | 10 | (15.6) | 0.942f | |
| p | 7 | (11.1) | 6 | (9.4) | 0.942f | |
| Current smoker | 7 | (11.1) | 14 | (21.9) | 0.151f | |
| First biological therapy | 44 | (69.8) | 43 | (67.2) | 0.896e | |
| Current anti-TNF therapy | infliximab (IFX) | 59 | (93.7) | 60 | (93.8) | 1.000e |
| adalimumab | 4 | (6.3) | 4 | (6.2) | 1.000e | |
| Mean duration of current anti-TNF treatment in months (range) | 34.9 | (3-137) | 35.9 | (3-129) | 0.914d | |
| Anti-TNF dose | 0.552f | |||||
| 10.0 mg/kg BW (IFX) | 26 | (41.3) | 27 | (42.2) | ||
| 7.5 mg/kg BW (IFX) | 10 | (15.9) | 5 | (7.8) | ||
| 5.0 mg/kg BW (IFX) | 23 | (36.5) | 28 | (43.8) | ||
| 40 mg (adalimumab) | 4 | (6.3) | 4 | (6.3) | ||
| Anti-TNF interval | 0.789d | |||||
| Every 8 weeks (IFX) | 24 | (38.1) | 25 | (39.1) | ||
| Every 7 weeks (IFX) | 7 | (11.1) | 7 | (10.9) | ||
| Every 6 weeks (IFX) | 10 | (15.8) | 7 | (10.9) | ||
| Every 5 weeks (IFX) | 9 | (14.3) | 7 | (10.9) | ||
| Every 4 weeks (IFX) | 9 | (14.3) | 14 | (21.9) | ||
| Every other week (adalimumab) | 3 | (4.8) | 3 | (4.7) | ||
| Every week (adalimumab) | 1 | (1.6) | 1 | (1.6) | ||
| Concomitant immunosuppressive medication | 7 | (11.1) | 3 | (4.7) | 0.206f | |
| methotrexate | 4 | (6.3) | 1 | (1.6) | ||
| azathioprine | 2 | (3.2) | 1 | (1.6) | ||
| prednisolone (7,5 mg/d) | 1 | (1.6) | 1 | (1.6) | ||
| Harvey-Bradshaw Index (HBI) b | ||||||
| 0-4 (clinical remission) | 33 | (52.3) | 40 | (62.5) | 1.000f | |
| 5-8 (mild disease) | 6 | (9.5) | 6 | (9.4) | 1.000f | |
| Partial Mayo Score (pMS) c | ||||||
| <2 (clinical remission) | 18 | (28.6) | 14 | (21.9) | 1.000f | |
| 2-4 (mild disease) | 5 | (7.9) | 4 | (6.3) | 1.000f | |
aIBD-unclassified was not classified via Montreal classification.
bOne patient of the intervention group hasn’t been scored by the physician at baseline. The physician documented “patient in clinical remission.”
cIBD-unclassified patients were scored via the pMS.
dWilcoxon rank sum test.
ePearson’s χ2 test.
fFisher’s exact Test.